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Surgi-Tip Transducer Cover

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 610-1072Ref 610-834Ref UA0073Ref UA0074

by Civco Medical Instruments Co., Inc.

Identity

Trade Name
Surgi-Tip Transducer Cover EUDAMEDFDA UDI
Generic Name
Intraoperative ultrasound imaging transducer cover FDA UDI
Device Name
General Purpose and Intraoperative Covers (Surgi-tip sterile) EUDAMED
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ tip FDA UDI
Sterile (15.2 x 244cm) polyethylene accordion-folded cover with attached (3cm) NeoGuard™ Tip FDA UDI
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ tip for use with BK Medical 8663, 8815, 8816, 8824, 8862, 8863 and N13C5 transducers FDA UDI
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip for use with BK Medical 10L2w, 13L4w, 14L3, 18L5, 8670, 8811, 8812, 8814, 8822 and 8870 transducers FDA UDI
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip FDA UDI
Model / Reference
610-1072 EUDAMEDFDA UDI
UA0073 EUDAMEDFDA UDI
UA0074 EUDAMEDFDA UDI
610-834 EUDAMEDFDA UDI
610-833 FDA UDI
Description
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ tip FDA UDI
Sterile (15.2 x 244cm) polyethylene accordion-folded cover with attached (3cm) NeoGuard™ Tip FDA UDI
Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ tip for use with BK Medical 8663, 8815, 8816, 8824, 8862, 8863 and N13C5 transducers FDA UDI
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip for use with BK Medical 10L2w, 13L4w, 14L3, 18L5, 8670, 8811, 8812, 8814, 8822 and 8870 transducers FDA UDI
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip FDA UDI

Identifiers

Catalog Number
610-833 FDA UDI
610-1072 FDA UDI
UA0073 FDA UDI
UA0074 FDA UDI
610-834 FDA UDI
Primary DI / UDI-DI
10841436101926 EUDAMEDFDA UDI
10841436110355 EUDAMEDFDA UDI
10841436110362 EUDAMEDFDA UDI
10841436104187 EUDAMEDFDA UDI
10841436104170 FDA UDI
Basic UDI-DI
0841436101TD201A12RM EUDAMED
510(k) Number
K013721 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
GMDN Term
Intraoperative ultrasound imaging transducer cover FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Length — 244 Centimeter FDA UDI
Width — 15 Centimeter FDA UDI
Width — 6 Inch FDA UDI
Length — 96 Inch FDA UDI
Width — 15.2 Centimeter FDA UDI
Width — 20.3 Centimeter FDA UDI
Width — 8 Inch FDA UDI

Category: Intraoperative ultrasound imaging transducer cover

Surgi-Tip Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative ultrasound imaging transducer cover.

Cleared under the same submission

K013721 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Civco Medical Instruments Co., Inc.

Sources (9)

  • FDA UDI c51e5e7e-c934-47e9-945f-90c932318217 38 fields · synced Oct 6, 2026
  • FDA UDI 16b5554d-17c7-4273-8cac-28e56a0d7b04 38 fields · synced May 29, 2026
  • FDA UDI 265b7a42-e9c8-4b2f-8417-5a62dd857897 38 fields · synced May 30, 2026
  • FDA UDI ba6d8b9d-088c-47f3-9908-eb9114090691 38 fields · synced May 30, 2026
  • FDA UDI 458e478f-7d00-4d9f-8089-7f70bee4741b 38 fields · synced May 30, 2026
  • EUDAMED 5b10e646-4c64-43bd-a2da-9aafaf07075b 61 fields · synced Jul 9, 2026
  • EUDAMED 02e4a401-497f-450f-9c83-1b39d017081e 61 fields · synced Jul 15, 2026
  • EUDAMED 284f5e7f-7bd9-4fa8-8bb2-f9f1e006f10b 61 fields · synced Jul 25, 2026
  • EUDAMED 08111744-f9cd-465b-aff5-4c073af13d18 61 fields · synced Jul 27, 2026